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Page 1 Private & Confidential NextPharma Technologies Holding Limited Sterile Product Development Centre (SPDC) At Braine-lAlleud, Belgium
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Page 2 Private & Confidential Benefits of the SPDC for You The SPDC can provide early and scale-up development for your sterile products SPDC can handle cytotoxic and biologics/conventional drugs in segregated units No site transfer involved during development of your product – which means less risk and resource Less risk as there is a seamless process from development through to commercialisation
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Page 3 Private & Confidential Benefits of the SPDC for You Expertise in lyophilisation Expertise in sterile formulation development An experienced development team transfers projects into commercial production. A wide range of packaging can be offered Global capability to service Europe, Japan, Canada, Brazil and USA (clinical) FDA compliance programme is in progress
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Page 4 Private & Confidential SPDC Sterile Product Handling Capabilities ProductsOELBiohazard Level CapabilitiesExclusions CytotoxicsLevel 4N/ASolutions (aqueous & alcohols), emulsion, suspension and lyophilised drugs. Solids BiologicalsLevel 4Level 2Peptides, proteins, Mabs, deactivated vaccines, growth hormones Live vaccines, live viruses, living organisms ConventionalsLevel 4N/ASolutions (aqueous), emulsions, suspensions and lyophilised drugs. Controlled drugs Radiopharmaceuticals, Beta-lactams
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Page 5 Private & Confidential SPDC Packaging Capabilities ProductsPackaging Capabilities CytotoxicsVials, pre-filled syringes, cartridges and kit assembly Clinical trial supplies labelling and packaging BiologicalsVials, pre-filled syringes, cartridges, ampoules and kit assembly Clinical trial supplies labelling and packaging. ConventionalsVials, pre-filled syringes, cartridges, ampoules and kit assembly Clinical trial supplies labelling and packaging
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Page 6 Private & Confidential The SPDC Facility Cyto GMP Unit Biologics / Conventional GMP Unit Storage and Final Packaging Area 2 QC Laboratories 2 Technical Development Labs (Formulation)
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Page 7 Private & Confidential The SPDC Facility in 3D
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Page 8 Private & Confidential GMP Layout – Cyto or Biological/Conventional Units Security lock - personal Corridor Pre-washing area C Personal lock Incoming material lock Security lock - material Large equipment installation lock Sterilization area Sterile material collection Technical area Compounding area Filling area B/C Personal lock – way out Security lock B/C Personal lock – way in Material lock - dispatch Emergency exit Decontamination area Emergency exit IPC Documentation
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Page 9 Private & Confidential GMP Layout – Cyto or Biological/Conventional Units Washing machine Packing after wash Storage cabinets + large equipment storage Depyrogenization oven (space for washing machine, tunnel) Autoclave Alcohol pass through Hot air passthrough Sterilizable (UV) passthrough Passthrough Compounding within RABS (Cyto) Filling machine Mobile 40 l vessel Freeze dryer Capping machine Sterile filtration /compounding within RABS (Cyto) Hand made decontamination and labeling Storage cabinets (inc. cold storage) IPC device Material handling trolley Stepover bench Fixed 40 l vessel Storage cabinets (inc. cold storage) Passthroughs Emergency shower
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Page 10 Private & Confidential Scope of Activities The SPDC will serve all early phase development needs (to Ph 2) for CMC (Chemistry, Manufacturing, Controls) data and clinical materials The facility will be able to develop Cytostatic, Biologics and other non-Cyto parenteral drugs in lyophilised or solution forms Drug forms can to be packed in a wide range of packagings: vials, cartridges, pre-filled syringes etc The facility can also develop eye drops, nasal preparations and other sterile forms in various packaging forms Design capacity of the SPDC is 150 batches per annum, operating on 1 shift/8 hour, 5 day week basis Offering 50 cyto GMP batches, 50 biologics/conventional GMP batches and 50 technical formulation batches per annum Direct staff numbers in the SPDC facility will be 27 persons, operating as a business unit at full capacity
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Page 11 Private & Confidential Clinical Development Capabilities Amongst the range of capabilities and activities to be done in each clinical area are: Cyto GMP area - has 1.6 m 2 freeze dryer, capable of up to 2000 standard (20 ml) size vials - has mix vessels of 0.4, 4 and 40 Lt, fully compliant with FDA and Thissen scale-up - can fill vials, pre-filled syringes and cartridges Biologics/conventionals GMP area - has 1.6 m 2 freeze dryer, capable of up to 8000 standard (5 ml) size vials - has mix vessels of 0.4, 4 and 40 Lt, fully compliant with FDA and Thissen scale-up - can fill vials, pre-filled syringes, cartridges and ampoules - can prepare diluents for cyto and bio/non-cyto kits
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Page 12 Private & Confidential Formulation, Analytical and Other Capabilities Amongst the capabilities and activities of the formulation and analytical areas are: Formulation area -has 1.3 m 2 lyophiliser, capable of up to 1600 standard (20 ml) size vials -has mix vessels of 0.4, 4 and 10 Lt, installed in RABS (restricted access barrier system) for cyto and bio work -can do pre-formulation work on cyto and bio, for compatibility, lyo cycles etc -can do preliminary work on filling of vials, pre-filled syringes and cartridges Analytical laboratories - full testing capability for biologics, cyto and non-cyto drugs - in-process test labs within cyto and biologics/conventional GMP areas - method development capability for biologics, cyto and conventional drugs - stability storage and testing capabilities, as part of Braine lAlleud facility Other services - has full cold-chain handling capability for cyto and biologics drugs
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